Method and apparatus for indicating the emergence of an ulcer

ABSTRACT

A method of monitoring a patient&#39;s foot forms a thermogram of the sole of at least one foot of the patient, and determines whether the thermogram presents at least one of a plurality of prescribed patterns. The method also compares the thermogram against a prior thermogram of the same foot, and produces output information indicating the emergence of an ulcer on a given portion on the at least one foot as a function of 1) whether the thermogram is determined to present the at least one pattern, and 2) the comparison with the prior thermogram, which shows non-ulcerated tissue at the given location.

PRIORITY

This patent application is a continuation application of U.S. patentapplication Ser. No. 17/459,656, filed Aug. 27, 2021, entitled, “METHODAND APPARATUS FOR INDICATING THE EMERGENCE OF AN ULCER,” attorney docketnumber 3891-11605, and naming David Robert Linders, Jonathan DavidBloom, Jeffrey Mark Engler, Brian Jude Petersen, Adam Geboff, and DavidCharles Kale as inventors, which is continuation application of U.S.patent application Ser. No. 15/056,611, filed Feb. 29, 2016, entitled,“METHOD AND APPARATUS FOR INDICATING THE EMERGENCE OF AN ULCER,”attorney docket number 3891-11601, and naming David Robert Linders,Jonathan David Bloom, Jeffrey Mark Engler, Brian Jude Petersen, AdamGeboff, and David Charles Kale as inventors, which is continuationapplication of U.S. patent application Ser. No. 13/799,847, filed Mar.13, 2013, entitled, “METHOD AND APPARATUS FOR INDICATING THE EMERGENCEOF AN ULCER,” attorney docket number 3891-10301, and naming David RobertLinders, Jonathan David Bloom, Jeffrey Mark Engler, Brian Jude Petersen,Adam Geboff, and David Charles Kale as inventors, which claims priorityfrom provisional U.S. Patent Application No. 61/618,889, filed Apr. 2,2012, entitled, “AUTONOMOUS METHOD FOR PREDICTING MEDICAL CONDITIONS INMAMMALS,” and naming Jonathan David Bloom, David Robert Linders, JeffreyMark Engler, David Charles Kale, and Adam Geboff as inventors. Thedisclosures of each of the above-noted patent applications areincorporated herein, in their entireties, by reference.

RELATED PATENT APPLICATIONS

This patent application is related to U.S. patent application Ser. No.14/662,738, filed Mar. 19, 2015, entitled, “METHOD AND APPARATUS OFMONITORING FOOT INFLAMMATION,” attorney docket number 3891/11301, andnaming Brian Petersen, Jonathan David Bloom, David Robert Linders, andJeffrey Mark Engler as inventors.

RELATED PATENTS

This patent application is related to the following patents, each ofwhich is incorporated herein, in its entirety, by reference:

1. U.S. Pat. No. 9,095,305, entitled, “METHOD AND APPARATUS FORINDICATING THE EMERGENCE OF A PRE-ULCER AND ITS PROGRESSION,” assignedattorney docket number 3891/10201, and naming Jeffrey Mark Engler, DavidRobert Linders, Jonathan David Bloom, Brian Petersen, Adam Geboff, andDavid Charles Kale and as inventors, and

2. U.S. Pat. No. 9,259,178, entitled, “METHOD AND APPARATUS FORINDICATING THE RISK OF AN EMERGING ULCER,” assigned attorney docketnumber 3891/10101, and naming Jonathan David Bloom, David RobertLinders, Jeffrey Mark Engler, Brian Jude Petersen, Adam Geboff, andDavid Charles Kale and as inventors.

FIELD OF THE INVENTION

The invention generally relates to ulcers on living beings and, moreparticularly, the invention relates to evaluating portions of livingbeings for ulcers.

BACKGROUND OF THE INVENTION

Open sores on an external surface of the body often form septic breedinggrounds for infection, which can lead to serious health complications.For example, foot ulcers on the bottom of a diabetic's foot can lead togangrene, leg amputation, or, in extreme cases, death. The healthcareestablishment therefore recommends monitoring a diabetic's foot on aregular basis to avoid these and other dangerous consequences.Unfortunately, known techniques for monitoring foot ulcers, among othertypes of ulcers, often are inconvenient to use, unreliable, orinaccurate, thus reducing compliance by the very patient populationsthat need it the most.

SUMMARY OF VARIOUS EMBODIMENTS

In accordance with one embodiment of the invention, a method ofmonitoring a patient's foot forms a thermogram of the sole of at leastone foot of the patient, and determines whether the thermogram presentsat least one of a plurality of prescribed patterns. The method alsocompares the thermogram against a prior thermogram of the same foot, andproduces output information indicating the emergence of an ulcer on agiven portion on the at least one foot as a function of 1) whether thethermogram is determined to present the at least one pattern, and 2) thecomparison with the prior thermogram, which shows non-ulcerated tissueat the given location.

Although it may show non-ulcerated tissue at a given location, the priorthermogram may show a pre-ulcer at that same location.

Moreover, the method may provide an open platform for receiving at leastone foot or both feet. Among other things, the open platform may have atleast one temperature sensor for generating a plurality of temperaturedata values after receipt of the at least one foot. The open platformmay be in the form of a floor mat. The plurality of temperature sensors(e.g., stationary and/or contact sensors) illustratively are at discretelocations on the foot. Accordingly a thermogram may be formed byinterpolating temperature data between at least two of the plurality oftemperature sensors to produce approximate and physically continuoustemperature readings at locations that are between the sensors. Thesensors may be contact sensors and/or be stationary.

Moreover, the platform may have a receiving area for receiving the atleast one foot, and/or for positioning both feet. The receiving area hasa surface area that is greater than the surface area of the at least onefoot. Accordingly, the thermogram can have data for substantially theentirety of the sole. In addition, unlike isotherms, the thermogramtypically is expected to have data showing substantially continuoustwo-dimensional spatial temperature variations across portions of the atleast one foot.

To indicate the emergence of an ulcer, the method may use any of anumber of different patterns. One shows a deviation in two portions ofthe same foot, while a second shows a deviation in correspondingportions of the patient's two feet. Another pattern shows a deviation inone portion of the same foot over time. The deviation may be atemperature deviation (e.g., about 4 degrees F.) at or across thespecified foot geography.

In addition to having any of a variety of different form factors, theopen platform often does not necessarily visually display thethermogram. Instead, its data often is used to determine the emergenceof a new ulcer without the need to display the thermogram. Moreover,some embodiments determine the orientation of the at least one foot toproduce orientation information, and then use that orientationinformation to determine whether the thermogram presents at least one ofa plurality of prescribed patterns.

Some embodiments forward, across a network, a data message having thetemperature data representing the thermogram. In response, someembodiments may receive a risk message, also from the network, havingthe output information. Among other things, output information mayinclude information for displaying quantitative indicia indicating theemergence of an ulcer.

Some embodiments form the thermogram by receiving a thermogram message(having temperature data of the sole) through a network from an openplatform, and forming the thermogram from the temperature data in thethermogram message. For example, the thermogram may be formed byinterpolating the received temperature data.

In accordance with other embodiments of the invention, an apparatus formonitoring a patient's foot has a thermogram generator configured toform a thermogram of the sole of at least one foot of the patient, and apattern recognition system (operatively coupled with the thermogramgenerator) configured to determine whether the thermogram presents atleast one of a plurality of prescribed patterns. The apparatus also hasa comparator (operatively coupled with the pattern recognition system)configured to compare the thermogram against a prior thermogram of thesame foot, and an analyzer (operatively coupled with the comparator)configured to produce output information indicating the emergence of anulcer on a given portion on the at least one foot as a function of 1)whether the thermogram is determined to present the at least onepattern, and 2) the comparison with the prior thermogram, which showsnon-ulcerated tissue at the given location.

Illustrative embodiments of the invention are implemented as a computerprogram product having a computer usable medium with computer readableprogram code thereon. The computer readable code may be read andutilized by a computer system in accordance with conventional processes.

BRIEF DESCRIPTION OF THE DRAWINGS

Those skilled in the art should more fully appreciate advantages ofvarious embodiments of the invention from the following “Description ofIllustrative Embodiments,” discussed with reference to the drawingssummarized immediately below.

FIG. 1 schematically shows a foot having a prominent foot ulcer and apre-ulcer.

FIG. 2A schematically shows one use and form factor that may beimplemented in accordance with illustrative embodiments of theinvention.

FIG. 2B schematically shows an open platform that may be configured inaccordance with illustrative embodiments of the invention.

FIG. 3A schematically shows an exploded view of one type of openplatform that may be configured in accordance with illustrativeembodiments of the invention.

FIG. 3B schematically shows a close up view of the platform with detailsof the pads and temperature sensors.

FIG. 4 schematically shows a network implementing of illustrativeembodiments of the invention.

FIG. 5 schematically shows an overview of various components ofillustrative embodiments of the invention.

FIG. 6 schematically shows details of a data processing module inaccordance with illustrative embodiments of the invention.

FIG. 7 shows a process of monitoring the health of the patient's foot orfeet in accordance with illustrative embodiments the invention.

FIG. 8 shows a process of forming a thermogram in accordance withillustrative embodiments of the invention.

FIGS. 9A-9D schematically show the progression of the thermogram and howit is processed in accordance with one embodiment of the invention.

FIGS. 10A and 10B schematically show two different types of patternsthat may be on the soles of a patient's foot indicating an ulcer orpre-ulcer.

FIGS. 11A and 11B schematically show two different user interfaces thatmay be displayed in accordance with illustrative embodiments of theinvention.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In illustrative embodiments, a method and apparatus analyze a patient'sfoot to determine whether a new ulcer has emerged on its underside(i.e., on its sole). This permits patients, their healthcare providers,and/or their caregivers to intervene earlier, reducing the risk of moreserious complications. To that end, an open platform receives thepatient's foot and generates temperature data that is processed to forma thermogram. If the thermogram presents at least one of a number ofprescribed patterns, then various embodiments produce output informationindicating the emergence of an ulcer on the patient's foot. Details ofillustrative embodiments are discussed below.

FIG. 1 schematically shows a bottom view of a patient's foot 10 that,undesirably, has an ulcer 12 and a pre-ulcer 14 (described below andshown in phantom since pre-ulcers 14 do not break through the skin). Asone would expect, an ulcer 12 on this part of the foot 10 typically isreferred to as a “foot ulcer 12.” Generally speaking, an ulcer is anopen sore on a surface of the body generally caused by a breakdown inthe skin or mucous membrane. Diabetics often develop foot ulcers 12 onthe soles of their feet 10 as part of their disease. In this setting,foot ulcers 12 often begin as a localized inflammation that may progressto skin breakdown and infection.

It should be noted that discussion of diabetes and diabetics is but oneexample and used here simply for illustrative purposes only.Accordingly, various embodiments apply to other types of diseases (e.g.,stroke, deconditioning, sepsis, friction, coma, etc. . . . ) and othertypes of ulcers—such embodiments may apply generally where there is acompression or friction on the living being's body over an extendedperiod of time. For example, various embodiments also apply to ulcersformed on different parts of the body, such as on the back (e.g.,bedsores), inside of prosthetic sockets, or on the buttocks (e.g., apatient in a wheelchair). Moreover, illustrative embodiments apply toother types of living beings beyond human beings, such as other mammals(e.g., horses or dogs). Accordingly, discussion of diabetic humanpatients having foot ulcers 12 is for simplicity only and not intendedto limit all embodiments of the invention.

Many prior art ulcer detection technologies known to the inventorssuffered from one significant problem—patient compliance. If a diseasedor susceptible patient does not regularly check his/her feet 10, thenthat person may not learn of an ulcer 12 or a pre-ulcer 14 until it hasemerged through the skin and/or requires significant medical treatment.Accordingly, illustrative embodiments implement an ulcer monitoringsystem in any of a variety of forms—preferably in an easy-to-use formfactor that facilitates and encourages regular use.

FIGS. 2A and 2B schematically show one form factor, in which apatient/user steps on an open platform 16 that gathers data about thatuser's feet 10. In this particular example, the open platform 16 is inthe form of a floor mat placed in a location where he the patientregularly stands, such as in front of a bathroom sink, next to a bed, infront of a shower, on a footrest, or integrated into a mattress. As anopen platform 16, the patient simply may step on the top sensing surfaceof the platform 16 to initiate the process. Accordingly, this and otherform factors favorably do not require that the patient affirmativelydecide to interact with the platform 16. Instead, many expected formfactors are configured to be used in areas where the patient frequentlystands during the course of their day without a foot covering.Alternatively, the open platform 16 may be moved to directly contact thefeet 10 of a patient that cannot stand. For example, if the patient isbedridden, then the platform 16 may be brought into contact with thepatient's feet 10 while in bed.

A bathroom mat or rug are but two of a wide variety of differentpotential form factors. Others may include a platform 16 resembling ascale, a stand, a footrest, a console, a tile built into the floor, or amore portable mechanism that receives at least one of the feet 10. Theimplementation shown in FIGS. 2A and 2B has a top surface area that islarger than the surface area of one or both of the feet 10 of thepatient. This enables a caregiver to obtain a complete view of thepatient's entire sole, providing a more complete view of the foot 10.

The open platform 16 also has some indicia or display 18 on its topsurface they can have any of a number of functions. For example, theindicia can turn a different color or sound an alarm after the readingsare complete, show the progression of the process, or display results ofthe process. Of course, the indicia or display 18 can be at any locationother than on the top surface of the open platform 16, such as on theside, or a separate component that communicates with the open platform16. In fact, in addition to, or instead of, using visual or audibleindicia, the platform 16 may have other types of indicia, such astactile indicia/feedback, our thermal indicia.

Rather than using an open platform 16, alternative embodiments may beimplemented as a closed platform 16, such as a shoe or sock that can beregularly worn by a patient, or worn on an as-needed basis. For example,the insole of the patient's shoe or boot may have the functionality fordetecting the emergence of a pre-ulcer 14 or ulcer 12, and/or monitoringa pre-ulcer 14 or ulcer 12.

To monitor the health of the patient's foot (discussed in greater detailbelow), the platform 16 of FIGS. 2A and 2B gathers temperature dataabout a plurality of different locations on the sole of the foot 10.This temperature data provides the core information ultimately used todetermine the health of the foot 10. FIG. 3 schematically shows anexploded view of the open platform 16 configured and arranged inaccordance with one embodiment of the invention. Of course, thisembodiment is but one of a number of potential implementation and, likeother features, is discussed by example only.

As shown, the platform 16 is formed as a stack of functional layerssandwiched between a cover 20 and a rigid base 22. For safety purposes,the base preferably has rubberized or has other non-skid features on itsbottom side. FIG. 3 shows one embodiment of this non-skid feature as anon-skid base 24. The platform 16 preferably has relatively thin profileto avoid tripping the patient and making it easy to use.

To measure foot temperature, the platform 16 has an array or matrix oftemperature sensors 26 fixed in place directly underneath the cover 20.More specifically, the temperature sensors 26 are positioned on arelatively large printed circuit board 28. The sensors 26 preferably arelaid out in a two-dimensional array/matrix of stationary contact sensorson the printed circuit board 28. The pitch or distance between thepreferably is relatively small, thus permitting more temperature sensors26 on the array. Among other things, the temperature sensors 26 mayinclude temperature sensitive resistors (e.g., printed or discretecomponents mounted onto the circuit board 28), thermocouples, fiberoptictemperature sensors, or a thermochromic film. Accordingly, when usedwith temperature sensors 26 that require direct contact, illustrativeembodiments form the cover 20 with a thin material having a relativelyhigh thermal conductivity. The platform 16 also may use temperaturesensors 26 that can still detect temperature through a patient's socks.

Other embodiments may use noncontact temperature sensors 26, such asinfrared detectors. Indeed, in that case, the cover 20 may have openingsto provide a line of sight from the sensors 26 to the sole of the foot10. Accordingly, discussion of contact sensors is by example only andnot intended to limit various embodiments. As discussed in greaterdetail below and noted above, regardless of their specific type, theplurality of sensors 26 generate a plurality of correspondingtemperature data values for a plurality of portions/spots on thepatient's foot 10 to monitor the health of the foot 10.

Some embodiments also may use pressure sensors for various functions,such as to determine the orientation of the feet 10 and/or toautomatically begin the measurement process. Among other things, thepressure sensors may include piezoelectric, resistive, capacitive, orfiber-optic pressure sensors. This layer of the platform 16 also mayhave additional sensor modalities beyond temperature sensors 26 andpressure sensors, such as positioning sensors, GPS sensors,accelerometers, gyroscopes, and others known by those skilled in theart.

To reduce the time required to sense the temperature at specific points,illustrative embodiments position an array of heat conducting pads 30over the array of temperature sensors 26. To illustrate this, FIG. 3Bschematically shows a small portion of the array of temperature sensors26 showing four temperature sensors 26 and their pads 30. Thetemperature sensors 26 are drawn in phantom because they preferably arecovered by the pads 30. Some embodiments do not cover the sensors 26,however, and simply thermally connect the sensors 26 with the pads 26.

Accordingly, each temperature sensor 26 has an associated heatconducting pad 30 that channels heat from one two-dimensional portion ofthe foot 10 (considered a two dimensional area although the foot mayhave some depth dimensionality) directly to its exposed surface. Thearray of conducting pads 30 preferably takes up the substantial majorityof the total surface area of the printed circuit board 28. The distancebetween the pads 30 thermally isolates them from one another, thuseliminating thermal short-circuits.

For example, each pad 30 may have a square shape with each side having alength of between about 0.1 and 1.0 inches. The pitch between pads 30thus is less than that amount. Accordingly, as a further detailedexample, some embodiments may space the temperature sensors 26 about 0.4inches apart with 0.25 inch (per side) square pads 30 oriented so thateach sensor 26 is at the center of the square pads 30. This leaves anopen region (i.e., a pitch) of about 0.15 inches between the square pads30. Among other things, the pads 30 may be formed from a film ofthermally conductive metal, such as a copper.

As suggested above, some embodiments do not use an array of temperaturesensors 26. Instead, such embodiments may use a single temperaturesensor 26 that can obtain a temperature reading of most or all of thesole. For example, a single sheet of a heat reactive material, such as athermochromic film (noted above), or similar apparatus should suffice.As known by those in the art, a thermochromic film, based on liquidcrystal technology, has internal liquid crystals that reorient toproduce an apparent change in color in response to a temperature change,typically above the ambient temperature. Alternatively, one or moreindividual temperature sensors 26, such as thermocouples or temperaturesensor resistors, may be movable to take repeated temperature readingsacross the bottom of the foot 10.

To operate efficiently, the open platform 16 should be configured sothat its top surface contacts substantially the entire sole of thepatient's foot 10. To that end, the platform 16 has a flexible andmovable layer of foam 32 or other material that conforms to the user'sfoot 10. For example, this layer should conform to the arch of the foot10. Of course, the sensors 26, printed circuit board 28, and cover 20also should be similarly flexible and yet robust to conform to the foot10 in a corresponding manner. Accordingly, the printed circuit board 28preferably is formed largely from a flexible material that supports thecircuit. For example, the printed circuit board 28 may be formedprimarily from a flex circuit that supports the temperature sensors 26,or it may be formed from strips of material that individually flex whenreceiving feet. Alternative embodiments may not have such flexibility(e.g., formed from conventional printed circuit board material, such asFR-4) and thus, produce less effective data.

The rigid base 22 positioned between the foam 32 and the non-skid base24 provides rigidity to the overall structure. In addition, the rigidbase 22 is contoured to receive a motherboard 34, a battery pack 36, acircuit housing 38, and additional circuit components that providefurther functionality. For example, the motherboard 34 may containintegrated circuits and microprocessors that control the functionalityof the platform 16.

In addition, the motherboard 34 also may have a user interface/indiciadisplay 18 as discussed above, and a communication interface 40 (FIG. 5) to connect to a larger network 44, such as the Internet. Thecommunication interface 40 may connect wirelessly or through a wiredconnection with the larger network 44, implementing any of a variety ofdifferent data communication protocols, such as Ethernet. Alternatively,the communication interface 40 can communicate through an embeddedBluetooth or other short range wireless radio that communicates with acellular telephone network 44 (e.g., a 3G or 4G network).

The platform 16 also may have edging 42 and other surface features thatimprove its aesthetic appearance and feel to the patient. The layers maybe secured together using one or more of an adhesive, snaps, nuts,bolts, or other fastening devices.

Although it gathers temperature and other data about the patient's foot,illustrative embodiments may locate additional logic for monitoring foothealth at another location. For example, such additional logic may be ona remote computing device. To that and other ends, FIG. 4 schematicallyshows one way in which the platform 16 can communicate with a largerdata network 44 in accordance with various embodiments the invention. Asshown, the platform 16 may connect with the Internet through a localrouter, through its local area network, or directly without anintervening device. This larger data network 44 (e.g., the Internet) caninclude any of a number of different endpoints that also areinterconnected. For example, the platform 16 may communicate with ananalysis engine 46 that analyzes the thermal data from the platform 16and determines the health of the patient's foot 10. The platform 16 alsomay communicate directly with a healthcare provider 48, such as adoctor, nurse, relative, and/or organization charged with managing thepatient's care. In fact, the platform 16 also can communicate with thepatient, such as through text message, telephone call, e-mailcommunication, or other modalities as the system permits.

FIG. 5 schematically shows a block diagram of a foot monitoring system,showing the platform 16 and the network 44 with its interconnectedcomponents in more detail. As shown, the patient communicates with theplatform 16 by standing on or being received in some manner by the arrayof sensors 26, which is represented in this figure as a “sensor matrix52.” A data acquisition block 54, implemented by, for example, themotherboard 34 and circuitry shown in FIG. 3 , controls acquisition ofthe temperature and other data for storage in a data storage device 56.Among other things, the data storage device 56 can be a volatile ornonvolatile storage medium, such as a hard drive, high-speedrandom-access-memory (“RAM”), or solid-state memory. The input/outputinterface port 40, also controlled by the motherboard 34 and otherelectronics on the platform 16, selectively transmits or forwards theacquired data from the storage device to the analysis engine 46 on aremote computing device, such as a server 60. The data acquisition block54 also may control the user indicators/displays 18, which providefeedback to the user through the above-mentioned indicia (e.g., audible,visual, or tactile).

As noted above and discussed in greater detail below with regard toFIGS. 7 and 8 , the analysis engine 46, on the remote server 60,analyzes the data received from the platform 16 in conjunction with ahealth data analytics module 62. A server output interface 64 forwardsthe processed output information/data from the analysis engine 46 andhealth data analytics module 62 toward others across the network 44,such as to a provider, a web display, or to the user via a phone, e-mailalert, text alert, or other similar way.

This output message may have the output information in its relativelyraw form for further processing. Alternatively, this output message mayhave the output information formatted in a high-level manner for easyreview by automated logic or a person viewing the data. Among otherthings, the output message may indicate the actual emergence of an ulcer12 or a pre-ulcer 14, the risk of the emergence of an ulcer 12 or apre-ulcer 14, or simply that the foot 10 is healthy and has no risks ofulcer 12 or pre-ulcer 14. In addition, this output message also may haveinformation that helps an end-user or healthcare provider 48 monitor anulcer 12 or pre-ulcer 14.

Using a distributed processing arrangement like that shown in FIG. 5 hasa number of benefits. Among other things, it permits the platform 16 tohave relatively simple and inexpensive components that are unobtrusiveto the patient. Moreover, this permits a “software-as-a-service”business model (“SAAS model”), which, among other things, permits moreflexibility in the functionality, typically easier patient monitoring,and more rapid functional updates. In addition, the SAAS modelfacilitates accumulation of patient data to improve analytic capability.

Some embodiments may distribute and physically position the functionalcomponents in a different manner. For example, the platform 16 may havethe analysis engine 46 on its local motherboard 34. In fact, someembodiments provide the functionality entirely on the platform 16 and/orwithin other components in the local vicinity of the platform 16. Forexample, all of those functional elements (e.g., the analysis engine 46and other functional elements) may be within the housing formed by thecover 20 and the rigid base 22. Accordingly, discussion of a distributedplatform 16 is but one of a number of embodiments that can be adaptedfor a specific application or use.

Those skilled in the art can perform the functions of the analysisengine 46 using any of a number of different hardware, software,firmware, or other non-known technologies. FIG. 6 shows severalfunctional blocks that, with other functional blocks, may be configuredto perform the functions of the analysis engine 46. This figure simplyshows the blocks and is illustrative of one way of implementing variousembodiments, while FIGS. 7 and 8 describe their functions in greaterdetail.

In summary, the analysis engine 46 of FIG. 6 has a thermogram generator66 configured to form a thermogram of the patient's foot 10 or feet 10based on a plurality of temperature readings from the bottom of the foot10, and a pattern recognition system 68 configured to determine whetherthe thermogram presents any of a number of different prescribedpatterns. Pattern data and other information may be stored in a localmemory 76. As discussed below, if the thermogram presents any of theseprescribed patterns, then the foot 10 may be unhealthy in some manner(e.g., having a pre-ulcer 14 or an ulcer 12).

The analysis engine 46 also has an analyzer 70 configured to produce theabove noted output information, which indicates any of a number ofdifferent conditions of the foot 10. For example, the output informationmay indicate the risk that an ulcer 12 will emerge, the emergence of apre-ulcer 14 (i.e., the first indication of a pre-ulcer 14), theprogression of a known ulcer 12, or the emergence of a new ulcer 12(i.e., the first indication of any given ulcer 12 to the patient andassociated support). Communicating through some interconnect mechanism,such as a bus 72 or network connection, these modules cooperate todetermine the status of the foot 10, which may be transmitted orforwarded through an input/output port 74 that communicates with theprior noted parties across the larger data network 44.

FIG. 7 shows a process that uses the various components described abovein FIGS. 1 through 6 to determine the health of the patient's foot 10.It should be noted that this process is a simplified, high level summaryof a much larger process and thus, should not be construed to suggestthat only these steps are required. In addition, some of the steps maybe performed in a different order than those described below. Althoughfunctions and processes of this process are described as being executedby the functional blocks in FIGS. 5 and 6 , some embodiments can beexecuted by other functional components.

The process begins at step 700, in which the platform 16 receives thepatient's feet 10 on its top surface, which may be considered a footreceiving area. For example, as shown in FIG. 2A, the patient may stepon the open platform 16 in front of the bathroom sink while washing herhands, brushing her teeth, or performing some other routine, frequentdaily task. Presumably, the platform 16 is energized before the patientsteps onto it. Some embodiments, however, may require that the platform16 be affirmatively energized by the patient turning on power in somemanner (e.g., actuating a power switch). Other embodiments, however,normally may operate in a low power, conservation mode (a “sleep mode”)that rapidly turns on in response to a stimulus, such as receipt of thepatient's feet 10.

Accordingly, the platform 16 controls the sensor array to measure thetemperature at the prescribed portions of the patient's foot/sole. Atthe same time, the user indicator display 18 may deliver affirmativefeedback to the patient by any of the above discussed ways. After thepatient steps on the platform 16, the temperature sensors 26 may take arelatively long time to ultimately make their readings. For example,this process can take between 30 to 60 seconds. Many people, however, donot have that kind of patience and thus, may step off the platform 16before it has completed its analysis. This undesirably can lead toinaccurate readings. In addition, these seemingly long delay times canreduce compliance.

The inventors recognized these problems. Accordingly, illustrativeembodiments of the invention do not require such long data acquisitionperiods. Instead, the system can use conventional techniques toextrapolate a smaller amount of real temperature data (e.g., a sparerset of the temperature data) to arrive at an approximation of the finaltemperature at each point of the foot. For example, this embodiment mayuse techniques similar to those used in high speed thermometers toextrapolate the final temperature data using only one to three secondsof actual temperature data.

This step therefore produces a matrix of discrete temperature valuesacross the foot 10 or feet 10. FIG. 9A graphically shows one example ofthis discrete temperature data for two feet 10. As discrete temperaturevalues, this representation does not have temperature information forthe regions of the foot 10 between the temperature sensors 26.Accordingly, using this discrete temperature data as shown in FIG. 9A,the process forms a thermogram of the foot 10 or feet 10 underexamination (step 702).

In simple terms, as known by those in the art, a thermogram is a datarecord made by a thermograph, or a visual display of that data record. Athermograph simply is an instrument that records temperatures (i.e., theplatform 16). As applied to illustrative embodiments, a thermographmeasures temperatures and generates a thermogram, which is data, or avisual representation of that data, of the continuous two-dimensionaltemperature data across some physical region, such as a foot 10.Accordingly, unlike an isothermal representation of temperature data, athermogram provides a complete, continuous data set/map of thetemperatures across an entire two-dimensional region/geography. Morespecifically, in various embodiments, a thermogram shows (withinaccepted tolerances) substantially complete and continuoustwo-dimensional spatial temperature variations and gradients acrossportions of the sole of (at least) a single foot 10, or across theentire sole of the single foot 10.

Momentarily turning away from FIG. 7 , FIG. 8 shows a process that step702 uses to form a thermogram. This discussion will return to FIG. 7 andproceed from step 702 after completing the thermogram formation processof FIG. 8 . It should be noted that, in a manner similar to FIG. 7 , theprocess of FIG. 8 is a simplified, high-level summary of a largerprocess and thus, should not be construed to suggest that only thesesteps are required. In addition, some of the steps may be performed in adifferent order than those described below. In a manner similar to thefunctions and processes of FIG. 7 , the functions and processesdescribed with regard to this process also can be executed by thefunctional blocks in FIGS. 5 and 6 , or by other functional components.

The process of forming a thermogram begins at step 800, in which thethermogram generator 66 of the analysis engine 46 receives the pluralityof temperature values, which, as noted above, are graphically shown byFIG. 9A. Of course, the thermogram generator 66 typically receives thosetemperature values as raw data. The depiction in FIG. 9A therefore issimply for illustration purposes only.

After receiving the temperature values, the process begins calculatingthe temperatures between the temperature sensors 26. To that end, theprocess uses conventional interpolation techniques to interpolate thetemperature values in a manner that produces a thermogram as noted above(step 802). Accordingly, for a thermogram of a planar thermodynamicsystem at steady state, the process may be considered to increase thespatial resolution of the data.

Among other ways, some embodiments may use Laplace interpolation betweenthe temperatures observed at each temperature sensor 26. Laplaceinterpolation is appropriate for this function given its physicalrelevance—the heat equation should simplify to the Laplace equationunder the assumption of steady state. The interpolant may be constructedby applying a second-order discrete finite difference Laplacian operatorto the data, imposing equality conditions on the known temperatures atthe sensors 26, and solving the resulting sparse linear system using aniterative solver, such as GMRES.

FIG. 9B schematically shows one example of the thermogram at this stageof the process. This figure should be contrasted with FIG. 9A, whichshows a more discrete illustration of the soles of the feet 10.

At this point, the process is considered to have formed the thermogram.For effective use, however, it nevertheless still may require furtherprocessing. Step 804 therefore orients the data/thermogram to a standardcoordinate system. To that end, the process may determine the locationof the sole of each foot 10, and then transform it into a standardcoordinate system for comparison against other temperature measurementson the same foot 10, and on the other foot 10. This ensures that eachportion of the foot 10 may be compared to itself from an earlierthermogram. FIG. 9C schematically shows one example of how this step mayreorient the thermogram of FIG. 9B.

The position and orientation of the foot 10 on the platform 16 thereforeis important when performing this step. For example, to determine theposition and orientation of the foot 10, the analysis engine 46 and itsthermogram generator 66 simply may contrast the regions of elevatedtemperature on the platform 16 (i.e., due to foot contact) with those atambient temperature. Other embodiments may use pressure sensors to forma pressure map of the foot 10.

The process may end at this point, or continue to step 806, to bettercontrast warmer portions of the foot 10 against other portions of thefoot 10. FIG. 9D schematically shows a thermogram produced in thismanner from the thermogram of FIG. 9C. This figure more clearly showstwo hotspots on the foot 10 than FIG. 9C. To that end, the processdetermines the baseline or normal temperature of the foot 10 for eachlocation within some tolerance range. The amount to which the actualtemperature of a portion of the foot 10 deviates from the baselinetemperature of that portion of the foot 10 therefore is used to morereadily show hotspots.

For example, if the deviation is negative, the thermogram may have someshade of blue, with a visual scale of faint blues being smallerdeviations and richer blues being larger deviations. In a similarmanner, positive deviations may be represented by some shade of red,with a visual scale of faint red being smaller deviations and richerreds being larger deviations. Accordingly, and this example, bright redportions of the thermogram readily show hotspots that may requireimmediate attention. Of course, other embodiments may use other colorsor techniques for showing hotspots. Accordingly, discussion of colorcoding or specific colors is not intended to limit all embodiments.

Now that the thermogram generator 66 has generated the thermogram, withbrighter hotspots and in an appropriate orientation, this discussionreturns to FIG. 7 to determine if the thermogram presents or shows anyof a number of prescribed patterns (step 704) and then analyzes anydetected pattern (step 706) to determine if there are hotspots. Inparticular, as noted, an elevated temperature at a particular portion ofthe foot 10 may be indicative or predictive of the emergence and risk ofa pre-ulcer 14 or ulcer 12 in the foot 10. For example, temperaturedeviations of about 2 degrees C. or about 4 degrees F. in certaincontexts can suggest emergence of an ulcer 12 or pre-ulcer 14.Temperature deviations other than about two degrees C. also may beindicative of a pre-ulcer 14 or ulcer 12 and thus, 2 degrees C. and 4degrees F. are discussed by example only. Accordingly, variousembodiments analyze the thermogram to determine if the geography of thefoot 10 presents or contains one or more of a set of prescribed patternsindicative of a pre-ulcer 14 or ulcer 12. Such embodiments may analyzethe visual representation of the thermograph, or just the data otherwiseused to generate and display a thermograph image—without displaying thethermograph.

A prescribed pattern may include a temperature differential over somegeography or portion of the foot 10 or feet 10. To that end, variousembodiments contemplate different patterns that compare at least aportion of the foot 10 against other foot data. Among other things,those comparisons may include the following:

1. A comparison of the temperature of the same portion/spot of the samefoot 10 at different times (i.e., a temporal comparison of the samespot),

2. A comparison of the temperatures of corresponding portions/spots ofthe patient's two feet 10 at the same time or at different times, and/or

3. A comparison of the temperature of different portions/spots of thesame foot 10 at the same time or at different times.

As an example of the first comparison, the pattern may show a certainregion of a foot 10 has a temperature that is 4 F higher than thetemperature at that same region several days earlier. FIG. 10Aschematically shows one example of this, in which a portion of the samefoot 10—the patient's left foot 10, has a spot with an increased risk ofulceration.

As an example of the second comparison, the pattern may show that thecorresponding portions of the patient's feet 10 have a temperaturedifferential that is 4 degrees F. FIG. 10B schematically shows anexample of this, where the region of the foot 10 on the left (the rightfoot 10) having a black border is hotter than the corresponding regionon the foot 10 on the right (the left foot 10).

As an example of the third comparison, the pattern may show localizedhotspots and peaks within an otherwise normal foot 10. These peaks maybe an indication of pre-ulcer 14 or ulcer 12 emergence, or increasedrisk of the same, which, like the other examples, alerts caregiver andpatient to the need for more vigilance.

Of course, various embodiments may make similar comparisons whileanalyzing the thermogram for additional patterns. For example, similarto the third comparison, the pattern recognition system 68 may have arunning average of the temperature of the geography of the entire foot10 over time. For any particular spot on the foot 10, this runningaverage may have a range between a high temperature and a lowtemperature. Accordingly, data indicating that the temperature at thatgiven spot is outside of the normal range may be predictive of apre-ulcer 14 or an ulcer 12 at that location.

Some embodiments may use machine learning and advanced filteringtechniques to ascertain risks and predictions, and to make thecomparisons. More specifically, advanced statistical models may beapplied to estimate the current status and health of the patient's feet10, and to make predictions about future changes in foot health. Stateestimation models, such as a switching Kalman filters, can process dataas they become available and update their estimate of the current statusof the user's feet 10 in real-time. The statistical models can combineboth expert knowledge based on clinical experience, and publishedresearch (e.g., specifying which variables and factors should beincluded in the models) with real data gathered and analyzed from users.This permits models to be trained and optimized based on a variety ofperformance measures.

Models can be continually improved as additional data is gathered, andupdated to reflect state-of-the-art clinical research. The models alsocan be designed to take into account a variety of potentiallyconfounding factors, such as physical activity (e.g., running),environmental conditions (e.g., a cold floor), personal baselines, pastinjuries, predisposition to developing problems, and problems developingin other regions (e.g., a rise in temperature recorded by a sensor 26may be due to an ulcer 12 developing in a neighboring region measured bya different sensor). In addition to using these models for deliveringreal-time analysis of users, they also may be used off-line to detectsignificant patterns in large archives of historical data. For example,a large rise above baseline temperature during a period of inactivitymay precede the development of an ulcer 12.

Alternative embodiments may configure the pattern recognition system 68and analyzer 70 to perform other processes that identify risk andemergence, as well as assist in tracking the progressions ulcers 12 andpre-ulcers 14. For example, if there is no ambient temperature data froma thermogram prior to the patient's use of the platform 16, then someembodiments may apply an Otsu filter (or other filter) first to the highresolution thermogram to identify regions with large temperaturedeviations from ambient. The characteristics of these regions (length,width, mean temperature, etc. . . . ) then may be statistically comparedto known distributions of foot characteristics to identify and isolatefeet 10. The right foot thermogram may be mirrored and an edge-alignmentalgorithm can be employed to standardize the data for hotspotidentification.

Two conditions can be evaluated independently for hotspotidentification. The first condition evaluates to true when aspatially-localized contralateral thermal asymmetry exceeds apre-determined temperature threshold for a given duration. The secondcondition evaluates to true when a spatially-localized ipsilateralthermal deviation between temporally successive scans exceeds apre-determined temperature threshold for a given duration. Theappropriate durations and thermal thresholds can be determined fromliterature review or through application of machine learning techniquesto data from observational studies. In the latter case, a support vectormachine or another robust classifier can be applied to outcome data fromthe observational study to determine appropriate temperature thresholdsand durations to achieve a desired balance between sensitivity andspecificity.

Illustrative embodiments have a set of prescribed patterns against whichthe pattern recognition system 68 and analyzer 70 compare to determinefoot health. Accordingly, discussion of specific techniques above areillustrative of any of a number of different techniques that may be usedand thus, are not intended to limit all embodiments of the invention.

The output of this analysis can be processed to produce risk summariesand scores that can be displayed to various users to trigger alerts andsuggest the need for intervention. Among other things, state estimationmodels can simulate potential changes in the user's foot 10 and assessthe likelihood of complications in the future. Moreover, these modelscan be combined with predictive models, such as linear logisticregression models and support vector machines, which can integrate alarge volume and variety of current and historical data, includingsignificant patterns discovered during off-line analysis. This may beused to forecast whether the user is likely to develop problems within agiven timeframe. The predictions of likelihood can be processed intorisk scores, which also can be displayed by both users and other thirdparties. These scores and displays are discussed in greater detailbelow.

To those ends, the process continues to step 708, which generates outputinformation relating to the health of the foot 10. Specifically, at thisstage in the process, the analysis engine 46 has generated the relevantdata to make a number of conclusions and assessments, in the form ofoutput information, relating to the health of the foot 10. Among otherthings, those assessments may include the risk of an ulcer 12 emerginganywhere on the foot 10, or at a particular location on the foot 10.This risk may be identified on a scale from no risk to maximum risk.

FIG. 11A shows one example of the output information in a visual formatwith a scale ranking the risk of ulcer emergence. The scale in thisexample visually displays de-identified patients (i.e., Patient A toPatient 2) as having a certain risk level of developing the foot ulcer12. The “Risk Level” column shows one way of graphically displaying theoutput information, in which more rectangles indicate a higher risk ofulcer 12. Specifically, in this example, a single rectangle may indicateminimal or no risk, while rectangles filling the entire length of thattable entry may indicate a maximum risk or fully emerged ulcer 12.Selection of a certain patient may produce an image of the foot 10 witha sliding bar showing the history of that patient's foot 10. FIG. 11Bschematically shows a similar output table in which the risk level ischaracterized by a percentage from zero to hundred percent within sometime frame (e.g., days). Patient C is bolded in this example due totheir 80 percent risk of the emergence of an ulcer 12.

The output table thus may provide the caregiver or healthcare providerwith information, such as the fact that Patient B has a 90 percentprobability that he/she will develop a foot ulcer 12 in the next 4-5days. To assist in making clinical treatment decisions, the clinicianalso may access the patient's history file to view the raw data.

Other embodiments produce output information indicating the emergence ofa pre-ulcer 14 at some spot on the foot 10. As known by those skilled inthe art, a pre-ulcer 14 may be considered to be formed when tissue inthe foot 10 is no longer normal, but it has not ruptured the top layerof skin. Accordingly, a pre-ulcer 14 is internal to the foot 10. Morespecifically, tissue in a specific region of the foot 10 may not bereceiving adequate blood supply and thus, may need more blood. When itdoes not receive an adequate supply of blood, it may become inflamed andsubsequently, become necrotic (i.e., death of the tissue). This createsa weakness or tenderness in that region of the foot 10. Accordingly, acallous or some event may accelerate a breakdown of the tissue, whichultimately may rupture the pre-ulcer 14 to form an ulcer 12.

Illustrative embodiments may detect the emergence of a pre-ulcer 14 inany of a number of manners described above. For example, the system maycompare temperature readings to those of prior thermograms, such as therunning average of the temperature at a given location. This comparisonmay show an elevated temperature at that spot, thus signaling theemergence of a new pre-ulcer 14. In more extreme cases, this mayindicate the actual emergence of a new ulcer 12.

The emergence or detection of a pre-ulcer 14 can trigger a number ofother preventative treatments that may eliminate or significantly reducethe likelihood of the ultimate emergence of an ulcer 12. To that end,after learning about a pre-ulcer 14, some embodiments monitor theprogression of the pre-ulcer 14. Preferably, the pre-ulcer 14 ismonitored during treatment in an effort to heal the area, thus avoidingthe emergence of an ulcer 12. For example, the caregiver may compareeach day's thermogram to prior thermograms, thus analyzing the most upto date state of the pre-ulcer 14. In favorable circumstances, during atreatment regimen, this comparison/monitoring shows a continuousimprovement of the pre-ulcer 14, indicating that the pre-ulcer 14 ishealing. The output information therefore can have current and/or pastdata relating to the pre-ulcer 14, and the risk that it poses for theemergence of an ulcer 12.

Sometimes, patients may not even realize that they have an ulcer 12until it has become seriously infected. For example, if the patientundesirably does not use the foot monitoring system for a long time,he/she may already have developed an ulcer 12. The patient therefore maystep on the platform 16 and the platform 16 may produce outputinformation indicating the emergence of an ulcer 12. To that end, theanalyzer 70 may have prior baseline thermogram (i.e., data) relating tothis patient's foot 10 (showing no ulcer), and make a comparison againstthat baseline data to determine the emergence of an actual ulcer 12. Incases where the data is questionable about whether it is an ulcer 12 ora pre-ulcer 14, the caregiver and/or patient nevertheless may benotified of the higher risk region of the foot 10 which, upon even acursory visual inspection, should immediately reveal the emergence of anulcer 12.

The process concludes at step 710, in which the process (optionally)manually or automatically notifies the relevant people about the healthof the foot 10. These notifications or messages (a type of “riskmessage”) may be in any of a number of forms, such as a telephone call,a text message, e-mail, and data transmission, or other similarmechanism. For example, the system may forward an e-mail to a healthcareprovider indicating that the right foot 10 of the patient is generallyhealthy, while the left foot 10 has a 20 percent risk of developing anulcer 12, and a pre-ulcer 14 also has emerged on a specified region.Armed with this information, the healthcare provider may takeappropriate action, such as by directing the patient to stay off theirfeet 10, use specialized footwear, soak their feet 10, or immediatelycheck into a hospital.

Accordingly, illustrative embodiments take advantage of the continuousdata provided by a thermogram to ascertain various risks to foot health.In addition, such embodiments also monitor the foot 10 using an easy tofollow regimen and form factor that encourages patient compliance. Earlydetection can assist in avoiding foot ulcers 12, while late detectioncan alert patients to yet undiscovered ulcers 12, which can then beeffectively treated.

Various embodiments of the invention may be implemented at least in partin any conventional computer programming language. For example, someembodiments may be implemented in a procedural programming language(e.g., “C”), or in an object oriented programming language (e.g.,“C++”). Other embodiments of the invention may be implemented aspreprogrammed hardware elements (e.g., application specific integratedcircuits, FPGAs, and digital signal processors), or other relatedcomponents.

In an alternative embodiment, the disclosed apparatus and methods (e.g.,see the various flow charts described above) may be implemented as acomputer program product (or in a computer process) for use with acomputer system. Such implementation may include a series of computerinstructions fixed either on a tangible medium, such as a computerreadable medium (e.g., a diskette, CD-ROM, ROM, or fixed disk) ortransmittable to a computer system, via a modem or other interfacedevice, such as a communications adapter connected to a network over amedium.

The medium may be either a tangible medium (e.g., optical or analogcommunications lines) or a medium implemented with wireless techniques(e.g., WIFI, microwave, infrared or other transmission techniques). Themedium also may be a non-transient medium. The series of computerinstructions can embody all or part of the functionality previouslydescribed herein with respect to the system. The processes describedherein are merely exemplary and it is understood that variousalternatives, mathematical equivalents, or derivations thereof fallwithin the scope of the present invention.

Those skilled in the art should appreciate that such computerinstructions can be written in a number of programming languages for usewith many computer architectures or operating systems. Furthermore, suchinstructions may be stored in any memory device, such as semiconductor,magnetic, optical or other memory devices, and may be transmitted usingany communications technology, such as optical, infrared, microwave, orother transmission technologies.

Among other ways, such a computer program product may be distributed asa removable medium with accompanying printed or electronic documentation(e.g., shrink wrapped software), preloaded with a computer system (e.g.,on system ROM or fixed disk), or distributed from a server or electronicbulletin board over the larger network 44 (e.g., the Internet or WorldWide Web). Of course, some embodiments of the invention may beimplemented as a combination of both software (e.g., a computer programproduct) and hardware. Still other embodiments of the invention areimplemented as entirely hardware, or entirely software.

Although the above discussion discloses various exemplary embodiments ofthe invention, it should be apparent that those skilled in the art canmake various modifications that will achieve some of the advantages ofthe invention without departing from the true scope of the invention.

1-3. (canceled)
 4. A method of predicting emergence of an ulcer on atleast one foot of a patient, wherein the at least one foot has a bottomsurface, the method comprising: positioning the at least one foot withina closed platform, the closed platform having a plurality of temperaturesensors, the closed platform comprising a flexible material configuredto conform substantially to at least a portion of the bottom surface ofthe at least one foot, said conforming causing the plurality oftemperature sensors to make contact with the at least a portion of thebottom of the at least one foot; generating, using the plurality oftemperature sensors, a plurality of discrete temperature data values ofthe at least one foot after said positioning the at least one footwithin the closed platform; ascertaining a level of physical activity ofthe patient; and determining whether the plurality of discretetemperature data values presents at least one of a plurality ofprescribed patterns indicative of an ulcer or pre-ulcer on the at leastone foot, said determining comprising: evaluating, using the pluralityof discrete temperature data values and an ulcer prediction model,whether a temperature variation of the at least one foot exceeds apre-determined threshold, the ulcer prediction model being a function ofthe level of physical activity of the patient, and producing, as afunction of evaluating, output information predicting emergence of anulcer or pre-ulcer on the at least one foot of the patient.
 5. Themethod as defined by claim 4 further comprising receiving an additionalset of discrete temperature data values representing temperature valuesof a second foot of the at least one foot, said evaluating comprisingusing the additional plurality of discrete temperature data values toevaluate whether a temperature variation of the at least one footexceeds the pre-determined threshold.
 6. The method as defined by claim4 wherein the closed platform comprises a sock.
 7. The method as definedby claim 4 wherein the closed platform comprises an insole.
 8. Themethod as defined by claim 4 wherein the closed platform comprises anaccelerometer, gyroscope, or both an accelerometer and gyroscope todetect movement of the closed platform.
 9. The method as defined byclaim 4 wherein the at least one foot comprise an arch, the flexiblematerial configured to conform the flexible material to the arch of theat least one foot.
 10. The method as defined by claim 4 wherein theplurality of temperature sensors are formed in an array.
 11. The methodas defined by claim 4 wherein the plurality of temperature sensors arenot formed in an array.
 12. The method as defined by claim 4 wherein theat least one foot of the patient comprises one foot, further wherein theplurality of prescribed patterns comprises the difference intemperatures being between two locations on one foot of the patient. 13.The method as defined by claim 4 wherein the at least one foot of thepatient comprises two feet of the patient, further wherein the pluralityof prescribed patterns comprises the difference in temperatures beingbetween two contralateral locations on the two feet of the patient. 14.The method as defined by claim 4 further comprising making temporallysuccessive thermal scans of one foot of the at least one foot, whereinthe plurality of prescribed patterns comprises the difference intemperatures at substantially the same location of the one foot acrossthe sequential thermal scans of the one foot.
 15. The method as definedby claim 4 further comprising forwarding the plurality of discretetemperature data values of the at least one foot to one or more remotecomputing devices, the one or more remote computing devices performingthe act of determining whether the plurality of discrete temperaturedata values presents at least one of the plurality of prescribedpatterns.
 16. The method as defined by claim 4 wherein predictingemergence of an ulcer or pre-ulcer includes predicting the location ofemergence of an ulcer or pre-ulcer on the at least one foot.
 17. Themethod as defined by claim 4 wherein the at least one foot comprises afirst foot and a second foot, said evaluating comprising evaluating,using the plurality of discrete temperature data values and an ulcerprediction model, whether a temperature variation between the first footand second foot exceeds the pre-determined threshold, said producingcomprising producing, as a function of evaluating, output informationpredicting emergence of an ulcer or pre-ulcer on the first foot of thepatient or on the second foot of the patient.
 18. A system forpredicting emergence of an ulcer on at least one foot of a patient,wherein the at least one foot has a bottom surface, the systemcomprising: a closed platform configured to receive the at least onefoot of the patient and having a plurality of temperature sensors, theclosed platform comprising a flexible material carrying the temperaturesensors, the closed platform configured to conform the flexible materialsubstantially to at least a portion of the bottom surface of the atleast one foot to contact the plurality of temperature sensors with theat least a portion of the bottom of the at least one foot, the pluralityof temperature sensors configured to generate a plurality of discretetemperature data values of the at least one foot after the closedplatform receives the at least one foot, the closed platform furthercomprising an accelerometer, a gyroscope, or both an accelerometer andgyroscope configured to produce motion data indicative of a level ofphysical activity of the patient, the closed platform further comprisinga communication interface configured to communicate with a communicationnetwork; and one or more processors configured to be in communicationwith the closed platform via the communication interface to receive theplurality of discrete temperature data values of the at least one footof the patient and the motion data, said one or more processorsconfigured to determine whether the plurality of discrete temperaturedata values presents at least one of a plurality of prescribed patternsindicative of an ulcer or pre-ulcer on the at least one foot, saidprocessor configured to determine by: evaluating, using the plurality ofdiscrete temperature data values and an ulcer prediction model, whethera temperature variation of the at least one foot exceeds apre-determined threshold, the ulcer prediction model being a function ofthe level of physical activity as specified by the motion data; and whenthe temperature variation is evaluated to exceed the pre-determinedthreshold, producing output information predicting emergence of an ulceror pre-ulcer on the at least one foot of the patient.
 19. The system asdefined by claim 18 wherein the closed platform comprises a sock or aninsole.
 20. The system as defined by claim 18 wherein the at least onefoot comprise an arch, the flexible material configured to conform theflexible material to the arch of the at least one foot.
 21. The systemas defined by claim 18 wherein the plurality of temperature sensors areformed in an array.
 22. The system as defined by claim 18 wherein theplurality of temperature sensors are not formed in an array.
 23. Thesystem as defined by claim 18 wherein the one or more processorscomprises means for evaluating whether a temperature variation of the atleast one foot exceeds a pre-determined threshold.
 24. The system asdefined by claim 18 wherein the one or more processors comprises meansfor producing the output information.
 25. The system as defined by claim18 wherein the communication interface comprises a wireless interfacewith the network.
 26. The system as defined by claim 18 wherein theplurality of temperature sensors comprises a plurality of temperaturesensitive resistors.
 27. The system as defined by claim 18 wherein theplurality of prescribed patterns comprises the difference intemperatures being between two locations on one foot of the patient. 28.The system as defined by claim 18 wherein the plurality of prescribedpatterns comprises the difference in temperatures being between twocontralateral locations on the two feet of the patient.
 29. The systemas defined by claim 18 wherein the plurality of prescribed patternscomprises the difference in temperatures at substantially the samelocation of one foot across time.